A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany

NCT06104644 | Active Not Recruiting FDA Drug

• 1 other identifier: IM011-250
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this observational study is to describe the effectiveness of deucravacitinib treatment and quality of life in adults with moderate-to-severe plaque psoriasis in routine clinical practice in Germany over a 5-year period

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 at Week 24 or nearest visit

  Approximately 24 weeks after treatment initiation (data to be collected at visit nearest to this timepoint)

Secondary Outcomes (15)

• Effectiveness of deucravacitinib treatment measured by the number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤ 3 and ≤ 6

  5 years

• Effectiveness of deucravacitinib treatment measured by the number of participants who achieve Psoriasis Area Severity Index (PASI) 75/90/100

  5 years

• Effectiveness of deucravacitinib treatment measured by the number of participants who achieved static Physician's Global Assessment (sPGA) 0/1 and change in sPGA over time

  5 years

• Effectiveness of deucravacitinib treatment measured by body surface area (BSA) affected by psoriasis and changes in BSA from baseline and over time

  5 years

• Effectiveness of deucravacitinib treatment in sensitive body areas measured by Physician's Global Assessment (PGA) for the genital area

  5 years

Study Arms (1)

Moderate-to-severe plaque psoriasis

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

Non-interventional observational study of patients receiving treatment with commercially available deucravacitinib 6 mg once daily according to the Summary of Product Characteristics

Moderate-to-severe plaque psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with moderate-to-severe plaque psoriasis in Germany

You may qualify if:

• Patients with a physician-reported diagnosis of moderate-to-severe plaque psoriasis initiating deucravacitinib according to approved label in the European Union
• The decision upon treatment with deucravacitinib must have been made before enrollment and independently of this non-interventional observational study
• Patient is at least 18 years of age at the time of treatment decision
• Patient provided written informed consent to participate in the study

You may not qualify if:

• Any contraindications according to the approved deucravacitinib Summary of Product Characteristics
• Prior treatment with deucravacitinib
• Simultaneous participation in an interventional clinical trial for moderate-to-severe psoriasis

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Dermatologische Spezial- und Schwerpunktpraxis Selters

Selters, Rhineland-Palatinate, Germany

Location

Local Institution - 0001

Selters, 56242, Germany

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

deucravacitinib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 27, 2023
• Study Start: April 13, 2023
• Primary Completion: August 18, 2025
• Study Completion (Estimated): May 31, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)